Commercial Quality Senior Manager - Brazil/South Cluster

About the role

Reporting to the Commercial Quality Senior Director, this position establishes and leads the quality management framework and quality system for the cluster, sets preventive and corrective actions to mitigate non-compliance risks and ensures compliance with world-class operational and customer-focused capabilities. It also leads regional projects and initiatives and represents the region in global projects. The role covers the Commercial Quality operations of the LatAm clusters (Brazil/Southern Cluster and Mexico/Northern Cluster).

Key responsibilities

• Lead the Cluster Commercial Quality organization and its quality assurance and quality systems.
• Manage CAPA and risk management processes, and develop strategic and process performance measures and targets.
• Establish and maintain relationships with partners and regulatory bodies, and oversee SOPs for simplicity, standardization and education.
• Ensure compliance with quality standards, local regulations and J&J policies, and lead the management review as Management Representative.
• Drive complaint vigilance, coordinate internal and second-party audits, and propose quality improvement initiatives.
• Manage Pharmacovigilance and Post-Market Surveillance (Technovigilance) systems within the cluster.
• Work with cross-segment leadership and external partners to strengthen quality and compliance capability through training, newsletters, conferences and quality week.

Required profile

• Bachelor's or master's degree in Business, Biosciences, Engineering, Chemistry, Pharmacy or a health-related discipline.
• Minimum 5 years of quality leadership experience, including at least 3 years in pharmaceutical, medical device or healthcare.
• Experience auditing, leading teams to quality improvements, and working with project management and statistical software.
• Strong communicator, negotiator and influencer; advanced English, Spanish and Portuguese is a plus.

Required skills

• Quality Management Systems (QMS), ISO 9001, CAPA, Quality Control (QC)
• Standard Operating Procedures (SOP), Compliance Management, Continuous Improvement
• Understanding of AI concepts and frameworks, including responsible and ethical AI practices